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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

EMA Confirms Safety of Combined Contraceptives

EU regulators have declared that they have found no new evidence that combined contraceptives present a greater safety risk to women than is currently known, a response they said was called for after "growing media reports" raised questions about the safety of the products.

Combined contraceptive medications, such as Bayer's Yasmin (drospirenone and ethylestradiol), have been associated with "very rare" thromboembolisms, and are closely monitored by both EU and US regulators.

In April 2012, the US Food and Drug Administration (FDA) issued a warning regarding all drospirenone-containing products, saying the hormone might be associated with a higher risk of thromboembolisms. It was not able to control the risk of drospirenone relative to the risk of other birth control products, it said, and was continuing to study the issue.

In a statement released on 11 January 2013, the European Medicines Agency (EMA) said it was aware of "no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today."

"Therefore," it added, "there is no reason for any woman to stop using her contraception." EMA explained that none of its member states had brought any issues related to the drugs, sometimes referred to as third-generation contraceptives, either.